HRSA 2024 Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+) FHIR IG
2.0.0 - STU2 Release 1 - Standard for Trial-Use International flag

This page is part of the HRSA Uniform Data System (UDS) Patient Level Submission (PLS) (UDS+ or uds-plus) FHIR IG (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: UDSPlusImmunization - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the uds-plus-immunization resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Immunization
Definition

The UDS+ profile is based on the Immunization resource and establishes the core elements, extensions, vocabularies and value sets for representing Immunizations for UDS+ program.


Describes the event of a patient being administered a vaccine or a record of an immunization as reported by a patient, a clinician or another party.

ShortDe-Identified UDS Plus ImmunizationImmunization event information
Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Immunization.id
Definition

De-dentified immunization resource identifier.


The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortThe de-identified Immunization identifier created by the health center to send data to UDS+ Data ReceiverLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
4. Immunization.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Immunization.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortCannot include any text in the resource as part of the de-identified data.Text summary of the resource, for human interpretation
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..01
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Immunization.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

ShortCannot include any contained resources in the resource as part of the de-identified data.Contained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Control0..0*
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
10. Immunization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. Immunization.status
Definition

Indicates the current status of the immunization event.

Shortcompleted | entered-in-error | not-done
Comments

Will generally be set to show that the immunization has been completed or not done. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control1..1
BindingThe codes SHALL be taken from ImmunizationStatusCodeshttp://hl7.org/fhir/ValueSet/immunization-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/immunization-status|4.0.1)

A set of codes indicating the current status of an Immunization.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains statuses entered-in-error and not-done which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Immunization.statusReason
Definition

Indicates the reason the immunization event was not performed.

ShortReason not done
Comments

This is generally only used for the status of "not-done". The reason for performing the immunization event is captured in reasonCode, not here.

Control0..1
BindingFor example codes, see ImmunizationStatusReasonCodeshttp://hl7.org/fhir/ValueSet/immunization-status-reason
(example to http://hl7.org/fhir/ValueSet/immunization-status-reason)

The reason why a vaccine was not administered.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Immunization.vaccineCode
Definition

Vaccine that was administered or was to be administered.

ShortVaccine product administered
Control1..1
BindingFor example codes, see VaccineAdministeredValueSethttp://hl7.org/fhir/ValueSet/vaccine-code
(example to http://hl7.org/fhir/ValueSet/vaccine-code)

The code for vaccine product administered.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Immunization.patient
Definition

The patient who either received or did not receive the immunization.

ShortWho was immunized
Control1..1
TypeReference(De-Identified UDS Plus Patient, Patient)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Immunization.patient.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

ShortText alternative for the resource
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control0..01
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Immunization.occurrence[x]
Definition

Date vaccine administered or was to be administered.

ShortVaccine administration date
Comments

When immunizations are given a specific date and time should always be known. When immunizations are patient reported, a specific date might not be known. Although partial dates are allowed, an adult patient might not be able to recall the year a childhood immunization was given. An exact date is always preferable, but the use of the String data type is acceptable when an exact date is not known. A small number of vaccines (e.g. live oral typhoid vaccine) are given as a series of patient self-administered dose over a span of time. In cases like this, often, only the first dose (typically a provider supervised dose) is recorded with the occurrence indicating the date/time of the first dose.

Control1..1
TypedateTime, string
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
uds-plus-imm-1: All dateTime data elements should be truncated to a year only for de-identified resources. ($this is DateTime implies $this.toString().length() = 4)
uds-plus-imm-1a: All dateTime data elements should have valid year > 1900 ($this is DateTime implies $this.toString() >= '1900')
uds-plus-imm-1b: All dateTime data elements should have valid year < 2030 ($this is DateTime implies $this.toString() <= '2030')
24. Immunization.recorded
Definition

The date the occurrence of the immunization was first captured in the record - potentially significantly after the occurrence of the event.

ShortWhen the immunization was first captured in the subject's record
Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
uds-plus-imm-2: All dateTime data elements should be truncated to a year only for de-identified resources. ($this is DateTime implies $this.toString().length() = 4)
uds-plus-imm-2a: All dateTime data elements should have valid year > 1900 ($this is DateTime implies $this.toString() >= '1900')
uds-plus-imm-2b: All dateTime data elements should have valid year < 2030 ($this is DateTime implies $this.toString() <= '2030')
26. Immunization.primarySource
Definition

An indication that the content of the record is based on information from the person who administered the vaccine. This reflects the context under which the data was originally recorded.

ShortIndicates context the data was recorded in
Comments

Reflects the “reliability” of the content.

Control10..1
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Immunization.expirationDate
Definition

Date vaccine batch expires.

ShortVaccine expiration date
Control0..1
Typedate
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
uds-plus-imm-3: All date data elements should be truncated to a year only for de-identified resources. ($this is date implies $this.toString().length() = 4)
uds-plus-imm-3a: All dateTime data elements should have valid year > 1900 ($this is DateTime implies $this.toString() >= '1900')
uds-plus-imm-3b: All dateTime data elements should have valid year < 2050 ($this is DateTime implies $this.toString() <= '2050')
30. Immunization.note
Definition

Extra information about the immunization that is not conveyed by the other attributes.

ShortAdditional immunization notes
Control0..0*
TypeAnnotation
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Immunization.isSubpotent
Definition

Indication if a dose is considered to be subpotent. By default, a dose should be considered to be potent.

ShortDose potency
Comments

Typically, the recognition of the dose being sub-potent is retrospective, after the administration (ex. notification of a manufacturer recall after administration). However, in the case of a partial administration (the patient moves unexpectedly and only some of the dose is actually administered), subpotency may be recognized immediately, but it is still important to record the event.

Control0..1
Typeboolean
Is Modifiertrue because This element is labeled as a modifier because an immunization event with a subpotent vaccine doesn't protect the patient the same way as a potent dose.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Meaning if MissingBy default, a dose should be considered to be potent.
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))